Traditional chinese medicine composition for preventing and treating metabolic-associated fatty liver disease, capsule, and use

Abstract

The present application provides a traditional Chinese medicine composition for preventing and treating metabolic-associated fatty liver disease, a capsule, and use. The traditional Chinese medicine composition is prepared from the following starting materials in parts by weight: 1-5 parts of Curcumae Longae Rhizoma extract, 10-20 parts of Puerariae Lobatae Radix extract, 15-30 parts of Salviae Miltiorrhizae Radix et Rhizoma extract, 1-10 parts of Schisandrae Chinensis Fructus extract, and 2-15 parts of Ganoderma extract. The preparation method for the capsule comprises the following steps: mixing the Curcumae Longae Rhizoma extract, the Puerariae Lobatae Radix extract, the Salviae Miltiorrhizae Radix et Rhizoma extract, the Schisandrae Chinensis Fructus extract, the Ganoderma extract, and maltodextrin uniformly, and filling the mixture into a hydroxypropyl methylcellulose hollow capsule to give the capsule. Salviae Miltiorrhizae Radix serves as the sovereign medicinal, Curcumae Longae Rhizoma and Puerariae Lobatae Radix serve as ministerial medicinals, and Schisandrae Chinensis Fructus and Ganoderma serve as adjuvant medicinals, such that the combination of such medicinals achieves the effects of protecting the liver, promoting blood circulation and regulating the flow of qi, promoting the production of body fluids and quenching thirst, tonifying qi for tranquillization, and the like. The present application can effectively prevent and treat metabolic-associated fatty liver disease and can treat non-alcoholic fatty liver disease, especially achieving a significant therapeutic effect on the non-alcoholic simple fatty liver and non-alcoholic steatohepatitis.

Description

A traditional Chinese medicine compound and capsule for the prevention and treatment of metabolic-related fatty liver disease and its application. Technical Field

[0001] This invention relates to the field of pharmaceutical preparation, and in particular to a traditional Chinese medicine complex, capsule, and application for the prevention and treatment of metabolic-related fatty liver disease. Background Technology

[0002] Non-alcoholic fatty liver disease (NAFLD) is a clinicopathological syndrome characterized by excessive fat deposition in hepatocytes caused by non-secondary factors (such as alcohol or drugs). Based on its natural progression, NAFLD broadly includes simple fatty liver (NAFL), steatohepatitis (NASH), cirrhosis, and related hepatocellular carcinoma. NAFLD is the most prevalent chronic liver disease globally, with a global prevalence of approximately 32%, and a prevalence of approximately 29% in China. Furthermore, the prevalence in the Asia-Pacific region continues to rise due to changes in dietary habits and lifestyles.

[0003] Statistics show that approximately 12-40% of NAFLD cases progress to NASH, about 15-25% of NASH cases progress to cirrhosis, and about 7% of cirrhosis cases progress to liver cancer. Therefore, NAFLD is considered a significant cause of hepatocellular carcinoma. The percentage of patients with NAFLD who develop cirrhosis, liver failure, or even require liver transplantation is increasing year by year, and it is projected to become a major cause of end-stage liver disease or liver transplantation in the future. Furthermore, as a common metabolic disease, NAFLD has become an independent risk factor for death from chronic diseases such as diabetes, cardiovascular disease, and cancer. Therefore, NAFLD has become a chronic disease that seriously endangers human health and imposes a huge economic burden on society, making research into its prevention and treatment urgently needed.

[0004] Research on NAFLD treatment drugs has attracted widespread attention. In April 2023, the US FDA approved Resmetirom for the treatment of NASH patients with liver fibrosis, making it the world's first NAFLD treatment drug. Currently, my country lacks specific drugs for NAFLD treatment approved and used clinically. It is well known that NAFL and NASH are early stages of NAFLD, and the liver lesions are reversible after removing the cause or effective treatment. Therefore, developing specific treatments for NAFL and NASH is of great significance for improving clinical cure rates, blocking or delaying the progression of NAFLD, and reducing the socioeconomic burden. Multi-target therapy is a unique advantage of traditional Chinese medicine in treating chronic, complex, and refractory diseases. Applying compound traditional Chinese medicine to conduct multi-target therapy targeting the complex etiology and pathogenesis of NAFLD holds promise as an effective approach to treating NAFLD. Summary of the Invention

[0005] In view of this, the present invention proposes a traditional Chinese medicine compound and capsule for the prevention and treatment of metabolic-related fatty liver disease and its application.

[0006] The technical solution of the present invention is as follows: a traditional Chinese medicine complex for the prevention and treatment of metabolic-related fatty liver disease is prepared from the following raw materials (medicinal materials) in parts by weight: 1-5 parts of turmeric extract, 10-20 parts of kudzu root extract, 15-30 parts of salvia miltiorrhiza extract, 1-10 parts of schisandra chinensis extract, and 2-15 parts of ganoderma lucidum extract.

[0007] Preferably, the traditional Chinese medicine complex is prepared from the following raw materials in parts by weight: 1-2 parts of turmeric extract, 12-16 parts of kudzu root extract, 15-20 parts of salvia miltiorrhiza extract, 3-5 parts of schisandra chinensis extract, and 4-6 parts of ganoderma lucidum extract.

[0008] More preferably, the traditional Chinese medicine complex is prepared from the following raw materials in parts by weight: 1 part turmeric extract, 14 parts kudzu root extract, 17 parts salvia miltiorrhiza extract, 3 parts schisandra chinensis extract, and 4 parts ganoderma lucidum extract.

[0009] Preferably, the preparation method of the danshen extract includes the following steps: take danshen, crush it, extract it with 90-95% v / v ethanol solution 2-3 times, each time for 0.5-1.5h, filter it to obtain filtrate and residue, extract the residue with water 2-3 times, each time for 0.5-1.5h, filter it, combine the filtrates, concentrate them, dry them, crush them and sieve them to obtain danshen extract.

[0010] Preferably, the preparation method of the turmeric extract includes the following steps: taking turmeric, crushing it, extracting it with 65-75% v / v ethanol solution for 3-5 hours, concentrating and crystallizing the extract, filtering, drying, crushing, and sieving to obtain the turmeric extract.

[0011] Preferably, the preparation method of the kudzu root extract includes the following steps: taking kudzu root, crushing it, extracting it 2-3 times with 65-75% v / v ethanol solution, each time for 0.5-1.5 hours, filtering, combining the filtrates, concentrating, drying, crushing, and sieving to obtain the kudzu root extract.

[0012] Preferably, the preparation method of Schisandra chinensis extract includes the following steps: take Schisandra chinensis, crush it, extract it with 75-85% v / v ethanol solution 2-3 times, filter it for 1-3 hours each time, combine the filtrates, concentrate it, dry it, pulverize it, sieve it and mix it to obtain Schisandra chinensis extract.

[0013] Preferably, the preparation method of the Ganoderma lucidum extract includes the following steps: taking Ganoderma lucidum, crushing it, adding water, heating it to 90-100℃ and decocting it 2-3 times, each time for 1-3 hours, filtering and combining the filtrates, concentrating, drying, and sieving to obtain the Ganoderma lucidum extract.

[0014] A capsule containing the traditional Chinese medicine complex described in any one of the present invention, wherein the preparation method of the capsule includes the following steps: taking turmeric extract, kudzu root extract, salvia miltiorrhiza extract, schisandra chinensis extract, ganoderma lucidum extract and maltodextrin, mixing them evenly to obtain capsule contents, and filling the capsule contents into hydroxypropyl methylcellulose empty capsules to obtain the capsule.

[0015] Furthermore, the mass percentage of maltodextrin in the capsule contents is 2-4%.

[0016] The traditional Chinese medicine compound described in any one of the present invention may be used in the preparation of a medicament for the prevention and / or treatment of metabolic-related fatty liver disease.

[0017] The traditional Chinese medicine compound described in any one of the present invention is used in the preparation of a medicament for treating non-alcoholic simple fatty liver and / or non-alcoholic fatty liver hepatitis.

[0018] Compared with the prior art, the beneficial effects of the present invention are:

[0019] This invention uses Salvia miltiorrhiza as the principal ingredient, Curcuma longa and Pueraria lobata as assistant ingredients, and Schisandra chinensis and Ganoderma lucidum as adjuvant ingredients. The combined effects of these ingredients achieve liver protection, blood circulation, qi regulation, thirst quenching, and calming the mind, effectively preventing and treating metabolic-related fatty liver disease. The drug (LJF) of this invention has unique advantages in treating non-alcoholic fatty liver disease (NAFLD), especially showing significant therapeutic effects on non-alcoholic simple fatty liver (NAFL) and non-alcoholic fatty liver hepatitis (NASH). This indicates that LJF has anti-fatty liver, lipid-lowering, liver lipid-lowering, transaminase-lowering, and liver-protective effects. Furthermore, with prolonged administration, LJF exhibits a significant weight-loss effect.

[0020] This invention uses Salvia miltiorrhiza as the principal ingredient; Salvia miltiorrhiza is bitter and slightly cold; it enters the heart and liver meridians; its functions are to invigorate blood and remove blood stasis, clear the heart and relieve irritability, cool the blood and eliminate carbuncles; Salvia miltiorrhiza is bitter and cold, it can not only invigorate blood and remove blood stasis, but also has the nourishing effect of helping the blood and qi of the heart and liver meridians return to normal, and belongs to the category of products that invigorate blood and nourish blood.

[0021] Turmeric and kudzu root are used as assistant herbs. Turmeric is pungent and bitter in taste, and warm in nature. It enters the spleen and liver meridians and functions to regulate qi. Turmeric enters the liver and spleen meridians, especially the blood aspect of the liver meridian, and promotes the flow of qi in the blood. It also regulates the qi stagnation in the liver and spleen, thus improving symptoms such as chest and rib pain and abdominal pain. Kudzu root is sweet and pungent in taste, and cool in nature. It enters the spleen, stomach, and lung meridians and functions to generate fluids and quench thirst. Sweetness enters the spleen meridian, which can raise spleen yang and lower stomach qi. Pungent and coolness can disperse heat. The spleen and stomach govern muscles, and the lungs govern skin and hair. Therefore, it can expel heat from the spleen and stomach through the muscles and pores to induce sweating. Pungent and coolness can disperse heat and relieve stiffness and pain in the neck and back caused by alcohol heat accumulating in the muscles and pores. Pungent and coolness can relieve thirst caused by alcohol heat scorching the stomach yin.

[0022] Schisandra chinensis and Ganoderma lucidum are used as adjuvant herbs. Schisandra chinensis is sour and sweet in taste, and warm in nature; it enters the lung, heart, and kidney meridians; its functions include astringing and consolidating, replenishing qi and generating fluids, tonifying the kidneys and calming the mind; it can improve yin and blood depletion, thirst due to fluid depletion, internal heat and thirst, palpitations and insomnia; Schisandra chinensis combined with Salvia miltiorrhiza, Curcuma longa, and Pueraria lobata, Salvia miltiorrhiza promotes blood circulation, Curcuma longa and Pueraria lobata disperse, and Schisandra chinensis astringes, which can restrain the principal and assistant herbs to prevent excessive dispersion and blood circulation. Moreover, the two dispersing herbs and one astringent herb, one promoting and one astringing herb, form a dynamic self-adjustment mode, complementing each other; Ganoderma lucidum is sweet in taste, and neutral in nature; it enters the heart, lung, liver, and kidney meridians; its functions include replenishing qi and calming the mind, relieving cough and asthma; it is used... For restlessness, insomnia, palpitations, cough and asthma due to lung deficiency, shortness of breath due to weakness, and loss of appetite, Ganoderma lucidum combined with Salvia miltiorrhiza, Curcuma longa, and Pueraria lobata invigorates blood circulation, promotes qi circulation, generates fluids and quenches thirst, while replenishing with cooling qi and calming the mind, thus assisting the body's overall self-adjustment and recovery. Ganoderma lucidum combined with Schisandra chinensis, one sweet and neutral to nourish the qi and yin of the five internal organs, and the other sour, sweet, and warm to nourish qi and blood, forms a prescription pattern that nourishes qi, yin, and blood simultaneously. The combined effects of these herbs can protect the liver, invigorate blood circulation, generate fluids and quench thirst, replenish qi and calm the mind, and can effectively prevent and treat metabolic-related fatty liver disease. Attached Figure Description

[0023] Figure 1: Effects of drug LJF on body weight, weight gain rate, and food consumption in NAFL model animals; A: Effects of LJF on body weight and weight gain rate in NAFL model animals ( #### P < 0.0001 (vs NC); B: Effect of LJF on food consumption in NAFL model animals.

[0024] [Corrected according to Rule 91, April 28, 2025] Figure 2: Effects of drug LJF on histopathological changes and scores of fatty liver in NAFL model mice; A: Histopathological images of liver (H&E staining, scale bar: 100 μm, triangles indicate small lipid droplets, pentagrams indicate large lipid droplets, small arrows indicate cell hypertrophy, and wide arrows indicate inflammatory cell aggregation); B: Total histopathological score of fatty liver and statistics of scores for small and large lipid droplets ( ### P < 0.001 vs NC, *P < 0.05, **P < 0.01 and ***P < 0.001 vs NAFL).

[0025] Figure 3: Effects of drug LJF on serum ALT and AST levels in NAFL model mice; ### P<0.001 vs NC, *P<0.05 vs NAFL.

[0026] Figure 4: Effects of drug LJF on liver TG and TC levels in NAFL mice; # P < 0.05 #### P<0.0001vs NC, *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001vs NAFL.

[0027] Figure 5: Effects of drug LJF on liver antioxidant function in NAFL model; ### P<0.001vs NC, *P<0.05, **P<0.01, ***P<0.001vs NAFL.

[0028] Figure 6: Effects of drug LJF on body weight, weight gain rate, and food consumption in NASH model animals; A: Effects of LJF on body weight and weight gain rate in NASH model animals ( #### P < 0.0001 vs NC * P < 0.05 ** P < 0.01 vs NASH); B: Effect of LJF on food consumption in NASH model animals.

[0029] [Corrected according to Rule 91, April 28, 2025] Figure 7: Effect of drug LJF on histopathological changes and NAS score of fatty liver in NASH model; A: Histopathological images of liver (H&E staining, scale bar: 100 μm, pentagrams indicate large lipid droplets, small arrows indicate ballooning degeneration, and wide arrows indicate inflammatory cell aggregation lesions); B: Statistical analysis of total NAS histopathological score and scores for fatty liver, ballooning degeneration, and inflammation ( #### P < 0.0001 vs NC * P < 0.05, ** P < 0.01 and *** P < 0.001 vs NASH

[0030] Figure 8: Effects of drug LJF on serum ALT and AST levels in a NASH model; ### P < 0.001 vs NC * P < 0.05 vs NASH.

[0031] Figure 9: Effects of drug LJF on liver TG and TC levels in NASH model; # P < 0.05 #### P < 0.0001 vs NC * P < 0.05 ** P < 0.01, *** P < 0.001, **** P < 0.0001 vs NASH.

[0032] Figure 10: Effects of drug LJF on liver antioxidant function in NASH model; ### P < 0.001 vs NC * P < 0.05 ** P < 0.01, ***P < 0.001, **** P < 0.0001 vs NASH. Detailed Implementation

[0033] To better understand the technical content of this invention, specific embodiments are provided below to further illustrate the invention.

[0034] Unless otherwise specified, the experimental methods used in the embodiments of this invention are all conventional methods.

[0035] Unless otherwise specified, all materials and reagents used in the embodiments of this invention are commercially available.

[0036] The turmeric extract, kudzu root extract, salvia miltiorrhiza extract, schisandra chinensis extract, and ganoderma lucidum extract used in Example 1 of this invention are commercially available products. Among them, the turmeric extract, calculated on a dried basis, contains curcumin (C...). 21 H 20 O6) ≥ 70%;

[0037] Pueraria lobata extract: based on dried product, contains puerarin (C 21 H 20 O9)≥8.0%;

[0038] Tanshinone extract: Calculated on a dried basis, contains tanshinone II. A (C 19 H 18 PO3) ≥ 0.4%;

[0039] Schisandra chinensis extract: based on dried product, contains schisandrol A (C 24 H 32 O7) ≥ 1.4%;

[0040] Ganoderma lucidum extract: Crude polysaccharide (calculated as glucose) ≥15.0%, as determined by the method specified in NY / T1676.

[0041] Example 1

[0042] 1 prescription

[0043] Drugs for the prevention and treatment of metabolic-related fatty liver disease: prepared from the following Chinese herbal extracts in parts by weight: 1 part turmeric extract, 14 parts kudzu root extract, 17 parts salvia miltiorrhiza extract, 3 parts schisandra chinensis extract, and 4 parts ganoderma lucidum extract.

[0044] 2 process

[0045] The capsule preparation method includes the following steps: take turmeric extract, kudzu root extract, salvia miltiorrhiza extract, schisandra chinensis extract, ganoderma lucidum extract and maltodextrin, the mass ratio of the Chinese herbal extracts to maltodextrin is 97:3, mix well, and fill into hydroxypropyl methylcellulose empty capsules to obtain the drug, abbreviated as LJF.

[0046] Example 2

[0047] 1 prescription

[0048] Drugs for the prevention and treatment of metabolic-related fatty liver disease: prepared from the following parts by weight of Chinese herbal extracts: 2 parts turmeric extract, 12 parts kudzu root extract, 20 parts salvia miltiorrhiza extract, 4 parts schisandra chinensis extract, and 5 parts ganoderma lucidum extract.

[0049] 2. The process is the same as in Example 1.

[0050] Example 3

[0051] 1 prescription

[0052] Drugs for the prevention and treatment of metabolic-related fatty liver disease: prepared from the following parts by weight of Chinese herbal extracts: 2 parts turmeric extract, 16 parts kudzu root extract, 15 parts salvia miltiorrhiza extract, 5 parts schisandra chinensis extract, and 6 parts ganoderma lucidum extract.

[0053] 2. The process is the same as in Example 1.

[0054] Experimental Example 1 - Animal Experiment - Therapeutic Effect of LJF on NAFL and NASH Models

[0055] 1.1 Model preparation and administration method: NAFL and NASH mouse models were established by feeding with a high-fat diet (60% fat). The success of the model was evaluated by the weight gain rate, pathological score of hepatic steatosis and serum transaminase level.

[0056] After successful animal model establishment, animals were divided into groups and treated with low, medium, and high doses of the capsules (LJF) from Example 1 via gavage, once daily for 8–12 weeks. The low-dose group (LJF-L): 250 mg / kg; the medium-dose group (LJF-M): 500 mg / kg; the high-dose group (LJF-H): 1000 mg / kg; and the negative control group (NC).

[0057] 1.2 Positive control drugs: Xuezhikang (XZK) was used as the positive control drug in the NAFL model, and silymarin (SIL) was used as the positive control drug in the NASH model. The dosage of the positive control drug was converted to the dosage for mice based on the clinical equivalent dose for human use.

[0058] 1.3 Pharmacodynamic evaluation indicators: weight change rate, food consumption, blood lipids, serum transaminase, fatty liver pathological score, hepatocyte lipid content and liver antioxidant function.

[0059] 2.1 Results of the NAFL model experiment: As shown in Figures 1-5 and Table 1, high-dose LJF significantly reduced the pathological score of fatty liver, serum ALT level, liver TG and TC content, and serum TG and TC levels in the NAFL model. Furthermore, low, medium, and high doses of LJF all significantly increased the GSH and SOD content in the liver tissue of the NAFL model. Wherein, TG: triglycerides; TC: total cholesterol; LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol; FFA: free fatty acids.

[0060] Conclusion: LJF administered continuously for 8 weeks has a therapeutic effect on a high-fat diet-induced NAFL mouse model, specifically by reducing fatty liver lesions, lowering blood lipids, lowering liver lipids, lowering transaminase levels, and protecting the liver.

[0061] Table 1. Effects of drug LJF on blood lipid levels in NAFL model animals (X±S) #### P≤0.0001 vs negative control group * P≤0.05, ** P≤0.01, *** P≤0.001 vs model group.

[0062] 2.2 Results of NASH model experiment: As shown in Figure 6-10 and Table 2, high dose of LJF significantly reduced the total pathological score of fatty liver in the NASH model, serum ALT level, liver TG and TC content, serum TG, LDL-C and FFA levels and body weight; and low, medium and high doses of LJF could significantly increase the content of GSH and SOD in liver tissue of the NASH model and reduce the content of MDA.

[0063] Conclusion: LJF administered continuously for 12 weeks has a therapeutic effect on a high-fat diet-induced NASH mouse model, specifically by reducing fatty liver lesions, lowering blood lipids, lowering liver lipids, reducing transaminase levels, protecting the liver, and reducing body weight.

[0064] Table 2. Effects of drug LJF on lipid levels in the NASH model (X±S) ## P≤0.01, #### P≤0.0001 vs negative control group * P≤0.05, ** P≤0.01 vs model group.

[0065] In summary, under the experimental conditions, compared with the commercially available drug Xuezhikang, the therapeutic advantages of drug LJF against NAFL are: (1) it can reduce serum transaminase ALT levels; (2) while lowering blood lipids, it can also increase serum high-density lipoprotein cholesterol (HDL-C) content to a certain extent.

[0066] Under the experimental conditions, the advantages of drug LJF in treating NASH compared with the commercially available drug silymarin are: (1) it has a lipid-lowering effect, such as reducing the levels of serum triglycerides (TG), low-density lipoprotein (LDL-C) and free fatty acids (FFA); (2) it can reduce the level of serum transaminase ALT; (3) it can increase the content of superoxide dismutase (SOD) in liver tissue; and (4) it has a weight-loss effect.

[0067] Example 4

[0068] The main difference from Example 1 lies in the preparation methods of turmeric extract, kudzu root extract, salvia miltiorrhiza extract, schisandra chinensis extract, and ganoderma lucidum extract. The preparation methods for turmeric extract, kudzu root extract, salvia miltiorrhiza extract, schisandra chinensis extract, and ganoderma lucidum extract are as follows:

[0069] (1) The preparation method of Danshen extract includes the following steps: take Danshen (Chinese medicinal material), crush it into coarse powder, add 95% v / v ethanol solution to extract twice according to the material-liquid ratio of 1:10 kg / L, the extraction temperature is 65℃±2℃, and the extraction time is 1 hour each time. Filter to obtain filtrate and filter residue. Add water to the filter residue to extract twice more, the material-liquid ratio of filter residue to water is 1:6 kg / L, the water extraction temperature is 95℃±5℃, and the extraction time is 1 hour each time. Filter, combine the filtrates, concentrate, dry, crush and sieve, mix and package.

[0070] (2) The preparation method of turmeric extract includes the following steps: take turmeric (Chinese medicinal material), crush it, add 70% v / v ethanol solution at a material-to-liquid ratio of 1:10 kg / L and extract for 4 hours at an extraction temperature of 67℃±2℃, concentrate the extract, crystallize and filter, dry, crush, sieve, mix and package.

[0071] (3) The preparation method of kudzu root extract includes the following steps: take kudzu root (Chinese medicinal material), crush it into coarse powder, add 70% v / v ethanol solution at a material-to-liquid ratio of 1:10 kg / L and extract twice, the extraction temperature is 72℃±2℃, each time for 1 hour, filter, combine the filtrates, concentrate, dry, crush and sieve, mix, and package.

[0072] (4) The preparation method of Schisandra chinensis extract includes the following steps: take Schisandra chinensis (Chinese medicinal material), crush it, add 80% v / v ethanol solution at a material-to-liquid ratio of 1:10 kg / L and extract twice, at an extraction temperature of 70℃±2℃, for 2 hours each time, filter, combine the filtrates, concentrate, dry, pulverize, sieve and mix, and package.

[0073] (5) The preparation method of Ganoderma lucidum extract includes the following steps: take Ganoderma lucidum (Chinese medicinal material), crush it, add water at a ratio of 1:8 kg / L and heat to 100℃ to decoct and extract twice, each time for 2 hours, filter and combine the filtrates, concentrate, dry, sieve and package.

[0074] The capsule preparation process is the same as in Example 1.

[0075] The low-dose group (250 mg / kg) of the capsules prepared in Example 4 of this invention showed better efficacy in treating non-alcoholic simple fatty liver (NAFL) than the medium-dose group (500 mg / kg) in Example 1, indicating that the capsules prepared in Example 4 have better efficacy.

[0076] Comparative Example 1

[0077] Following the method in Example 1, turmeric extract, kudzu root extract, salvia miltiorrhiza extract, schisandra extract, and ganoderma extract were respectively prepared into capsules to obtain turmeric capsules, kudzu root capsules, salvia miltiorrhiza capsules, schisandra capsules, and ganoderma capsules.

[0078] The efficacy test was conducted according to Experiment Example 1, and the efficacy tests were carried out on turmeric capsules, kudzu root capsules, salvia miltiorrhiza capsules, schisandra chinensis capsules, and ganoderma lucidum capsules, which were respectively designated as experimental groups 1-5.

[0079] The experimental results showed that, compared with Example 1, the high-dose groups 1-5 (1000 mg / kg) of the experimental groups were inferior to the low-dose group (250 mg / kg) of Example 1 in terms of therapeutic effect on NAFL mice and NASH mice.

[0080] Comparative Example 2

[0081] Based on Example 1, the prescription was supplemented with wolfberry, mulberry, and angelica. Wolfberry, mulberry, and angelica were soaked in hot water at 80℃ and then decocted for 2 hours. The decoction was collected and spray-dried to obtain a mixed herbal extract. The capsule prescription was prepared from the following herbal extracts in parts by weight: 2 parts turmeric extract, 10 parts kudzu root extract, 20 parts salvia miltiorrhiza extract, 3 parts schisandra chinensis extract, 10 parts ganoderma lucidum extract, and 10 parts mixed herbal extract. The high-dose group (1000 mg / kg) of this capsule showed significantly inferior efficacy in treating NAFL and NASH mice compared to the high-dose group in Example 1.

[0082] Comparative Example 3

[0083] The main difference from Example 1 is that the tanshinone extract is replaced with milk thistle extract. The preparation method of milk thistle extract is as follows: milk thistle is taken, crushed, water is added at a material-to-liquid mass ratio of 1:6, heated to 100°C and decocted for 3 hours, filtered, the filtrate is collected, and the filtrate is concentrated under vacuum to a concentration of 0.7 g / ml to obtain milk thistle extract.

[0084] Drug prescription: Prepared from the following parts by weight of traditional Chinese medicine extracts: 1 part turmeric extract, 14 parts kudzu root extract, 17 parts milk thistle extract, 3 parts schisandra extract, and 4 parts ganoderma extract. Capsule preparation method includes the following steps: Take appropriate amounts of turmeric extract, kudzu root extract, milk thistle extract, schisandra extract, ganoderma extract, and maltodextrin, with a mass ratio of traditional Chinese medicine extracts to maltodextrin of 97:3, mix well, and fill into hydroxypropyl methylcellulose empty capsules to obtain the drug.

[0085] Results: The high-dose group (1000 mg / kg) of the capsules prepared in Comparative Example 3 was less effective in treating NAFL mice and NASH mice than the low-dose group (250 mg / kg) in Example 1.

[0086] [Revised according to Article 91, 28.04.2025] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine compound for the prevention and treatment of metabolic-related fatty liver disease, characterized in that, It is prepared from the following raw materials in parts by weight: 1-5 parts turmeric extract, 10-20 parts kudzu root extract, 15-30 parts salvia miltiorrhiza extract, 1-10 parts schisandra chinensis extract, and 2-15 parts ganoderma lucidum extract.

2. The traditional Chinese medicine complex according to claim 1, characterized in that, It is prepared from the following raw materials in parts by weight: 1-2 parts turmeric extract, 12-16 parts kudzu root extract, 15-20 parts salvia miltiorrhiza extract, 3-5 parts schisandra chinensis extract, and 4-6 parts ganoderma lucidum extract.

3. The traditional Chinese medicine complex according to claim 2, characterized in that, It is prepared from the following raw materials in parts by weight: 1 part turmeric extract, 14 parts kudzu root extract, 17 parts salvia miltiorrhiza extract, 3 parts schisandra chinensis extract, and 4 parts ganoderma lucidum extract.

4. The traditional Chinese medicine complex according to claim 2, characterized in that, The preparation method of the danshen extract includes the following steps: take danshen, crush it, extract it with 90-95% v / v ethanol solution 2-3 times, each time for 0.5-1.5h, filter it to obtain filtrate and residue, extract the residue with water 2-3 times, each time for 0.5-1.5h, filter it, combine the filtrates, concentrate it, dry it, crush it and sieve it to obtain danshen extract.

5. The traditional Chinese medicine complex according to claim 2, characterized in that, The preparation method of the turmeric extract includes the following steps: take turmeric, crush it, add 65-75% v / v ethanol solution to extract for 3-5 hours, concentrate and crystallize the extract, filter, dry, crush, and sieve to obtain turmeric extract; The preparation method of the kudzu root extract includes the following steps: take kudzu root, crush it, extract it 2-3 times with 65-75% v / v ethanol solution, each time for 0.5-1.5h, filter it, combine the filtrates, concentrate it, dry it, crush it, and sieve it to obtain the kudzu root extract. The preparation method of the Schisandra chinensis extract includes the following steps: take Schisandra chinensis, crush it, extract it with 75-85% v / v ethanol solution 2-3 times, filter it for 1-3 hours each time, combine the filtrates, concentrate it, dry it, pulverize it, sieve it and mix it to obtain the Schisandra chinensis extract.

6. The traditional Chinese medicine compound according to claim 2, characterized in that, The preparation method of the Ganoderma lucidum extract includes the following steps: take Ganoderma lucidum, crush it, add water, decoct and extract 2-3 times, each time for 1-3 hours, filter and combine the filtrates, concentrate, dry, and sieve to obtain Ganoderma lucidum extract.

7. A capsule containing the traditional Chinese medicine complex according to any one of claims 1-3, characterized in that, The preparation method of the capsule includes the following steps: take turmeric extract, kudzu root extract, salvia miltiorrhiza extract, schisandra chinensis extract, ganoderma lucidum extract and maltodextrin, mix them well to obtain capsule contents, and fill the capsule contents into hydroxypropyl methylcellulose empty capsules to obtain the capsule.

8. The capsule according to claim 7, characterized in that, The mass percentage of maltodextrin in the contents of the capsule is 2-4%.

9. The use of the traditional Chinese medicine compound according to any one of claims 1-3 in the preparation of a medicament for the prevention and / or treatment of metabolic-related fatty liver disease.

10. The traditional Chinese medicine compound according to any one of claims 1-3 is used in the preparation of a medicament for treating non-alcoholic simple fatty liver and / or non-alcoholic fatty liver hepatitis.

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